Saroglitazar vs obeticholic acid in patients of fatty liver.

Phase 3

• Conditions: Health Condition 1: K740- Hepatic fibrosis

• Registration Number: CTRI/2023/03/050213
• Lead Sponsor: Department of Medical gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 6 March 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adults (age 18 to 60) being managed or treated for NAFLD.

•The patient must qualify for NAFLD, according to the American Association for the Study of Liver Diseases (AASLD) criteria (Chalasani et al.2017).

•(a) There is hepatic steatosis by imaging or histology,

•(b) There is no significant alcohol consumption,

•(c) There are no competing aetiologies for hepatic steatosis

•(d) There are no co-existing causes for chronic liver disease.

•Patientâ??s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.

•The subjects underwent Fibroscan per the protocol described prior to enrolment and subsequently, they were contacted to participate in the follow-up study at 24 .

•The lipid profile range in the inclusion criteria. TG >= 150mg/dl and LDL >= 100mg /dL and HDL <= 40 mg /dL.

Exclusion Criteria

Presence of regular or excessive use of alcohol within 2 years prior to initial screening.

Presence of alternative causes of fatty liver, including:

History of bowel surgery, gastrointestinal (bariatric) surgery or undergoing evaluation for bariatric surgery for obesity, extensive small-bowel resection, or orthotopic liver transplants (OLT)

History of other chronic liver disease (Viral hepatitis B or C, autoimmune hepatitis, cholestatic and metabolic liver diseases) and hemochromatosis

Study & Design

• Study Type: Interventional
• Study Design: Not specified